Duns Number:557804864
Device Description: Medizs Auto Refractometer-Keratometer RK-11 is a refraction device to measure Both of Refr Medizs Auto Refractometer-Keratometer RK-11 is a refraction device to measure Both of Refractometry & Keratometry.And also, it is able to take patient's PD, Axis and Cylinder value for a prescription of vision correction.
Catalog Number
RK-11
Brand Name
Medizs Auto Refractometer-Keratometer
Version/Model Number
RK-11
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HKO
Product Code Name
Refractometer, Ophthalmic
Public Device Record Key
85525365-eb8d-45a7-81d7-2e70969c8660
Public Version Date
March 31, 2021
Public Version Number
1
DI Record Publish Date
March 23, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |